US FDA Advisory Committees As The Court Of Appeals
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.
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Ardelyx’s Tenapanor: FDA Panel To Weigh Treatment Effect Size In Context Of Approved Agents
Agency previously declined to approved tenapanor for the control of serum phosphorous levels in chronic kidney disease patients on dialysis, saying the magnitude of treatment effect on a surrogate endpoint in three clinical trials was less than that observed with approved drugs and of unclear significance.
House GOP Targets US FDA Applications With China-Only Data, Cites General Oversight Concerns
While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.
House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.